Cleared Traditional

K800594 - VENTRE/SEP CORTISOL RIA

K800594 is the FDA 510(k) clearance for VENTRE/SEP CORTISOL RIA by Ventrex Laboratories, Inc.. It is a Class 2 Chemistry device (product code CGR) cleared through the Traditional 510(k) pathway after a 18-day FDA review.

K800594 · Ventrex Laboratories, Inc. · Chemistry device
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Apr 1980
Decision
18d
Days
Class 2
Risk

K800594 is an FDA 510(k) clearance for the VENTRE/SEP CORTISOL RIA. Classified as Radioimmunoassay, Cortisol (product code CGR), Class II - Special Controls.

Submitted by Ventrex Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on April 4, 1980 after a review of 18 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1205 - the FDA in vitro diagnostics and chemistry framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Ventrex Laboratories, Inc. devices

Submission Details

510(k) Number K800594 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 17, 1980
Decision Date April 04, 1980
Days to Decision 18 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
70d faster than avg
Panel avg: 88d · This submission: 18d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CGR Radioimmunoassay, Cortisol
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1205
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Chemistry devices follow this clearance model.

Regulatory Peers - CGR Radioimmunoassay, Cortisol

All 45
Devices cleared under the same product code (CGR) and FDA review panel - the closest regulatory comparables to K800594.
ARIA II 125 I CORTISOL
K802380 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Oct 1980
CORTISOL125 RADIOIMMUNOASSAY
K802036 · Corning Medical & Scientific · Oct 1980
AMERLEX CORTISOL RIA KIT
K800700 · Amersham Corp. · Apr 1980
EMIT AUTO CORTISOL ASSAY
K800245 · Syva Co. · Mar 1980
QUANTIMUNE CORTISOL RIA CORTISOL RADIO-
K800045 · Bio-Rad · Jan 1980
ANALYTE CORTISOL
K792439 · Technicon Instruments Corp. · Jan 1980